MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576

MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576 is an FDA 510(k)-cleared medical device (K053539) manufactured by Baxter Healthcare Corporation. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 23, 2006. Regulation: 8.